BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH SLIDEMAKER

    MDR report key: 2579236 · Received May 17, 2012

    Report

    Report Number
    1061932-2012-01639
    Event Type
    Malfunction
    Date Received
    May 17, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE WASTE WAS SLOW TO DRAIN. THE FSE REPLACED THE TUBING TO THE WASTE CHAMBER, THE EXTERNAL WASTE TUBING, AND QUICK DISCONNECT TO RESOLVE THE LEAK ISSUE. SERVICE ACTIVITY PERFORMED AND VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER HAS AN EXPOSURE CONTROL MANAGEMENT PLAN AT THE FACILITY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAKED INSIDE THE UNIT INVOLVING COULTER LH SLIDEMAKER. THE CUSTOMER STATED THE FLUID DRIPPED ON THE DRIP TRAY FOR THE PAST TWO DAYS. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT DURING THE INCIDENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS INCIDENT. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1